II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--dfma-medical-device
dfma-medical-device overview
Design for Manufacturing and Assembly (DFMA) - Optimize medical device designs for efficient, consistent, and reliable manufacturing while maintaining quality and regulatory compliance.
Attributes
displayName
dfma-medical-device
description
Design for Manufacturing and Assembly (DFMA) - Optimize medical device designs for efficient,
consistent, and reliable manufacturing while maintaining quality and regulatory compliance.
libraryPath
library/specializations/domains/science/biomedical-engineering/dfma-medical-device.js
specialization
biomedical-engineering
references
- - DFMA Guidelines: https://www.dfma.com/ - FDA Quality System Regulation 21 CFR 820 - ISO 13485:2016 Section 7.3.3 Design and Development Outputs
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/dfma-medical-device', {
deviceName: 'Disposable Surgical Stapler',
designOutputs: [{ component: 'Staple cartridge', material: 'Medical grade ABS' }],
manufacturingProcesses: ['Injection molding', 'Assembly', 'Sterilization'],
qualityRequirements: { defectRate: '<0.1%', cpk: '>1.33' }
});
usesAgents
- general-purpose
Outgoing edges
lib_applies_to_domain1
- domain:biomedical-engineering·DomainBiomedical Engineering
lib_belongs_to_specialization1
- specialization:biomedical-engineering·SpecializationBiomedical Engineering
lib_implements_workflow2
- workflow:experiment-design·WorkflowExperiment Design
- workflow:peer-review-cycle·WorkflowPeer Review Cycle
lib_involves_role2
- role:biomedical-engineer·RoleBiomedical Engineer
- role:research-engineer·RoleResearch Engineer
lib_requires_skill_area3
- skill-area:data-analysis·SkillAreaData Analysis
- skill-area:sensor-fusion·SkillAreaSensor Fusion
- skill-area:statistical-analysis·SkillAreaStatistical Analysis
Incoming edges
None.